FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Butterfly iQ/iQ+ Ultrasound System
K Number: K220068
·
Decision Mar 31, 2023
Classifications
1
FEI Numbers
345
Registration Numbers
346
Same Product Code
883
Applicant Total
4
Review Days
445
Basic Information
- Device Name
- Butterfly iQ/iQ+ Ultrasound System
- K Number
- K220068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Butterfly Network, Inc.
- Date Received
- January 10, 2022
- Decision Date
- March 31, 2023
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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